Softgel enteric coating technologies applied in Nutralab facilities

Softgel enteric coating technologies applied in Nutralab facilities. To meet the increasing demand for softgel supplement products, Nutralab Canada has currently completed his in-house advanced facilities for softgel manufacturing. It allows Nutralab softgel production capacities up to 2.0 million softgel (oval #10) daily. It would help to shorthorn the lead-time for the current growing demand for the Canadian quality softgel products.

As a high demand for enteric coated pharmaceutical and dietary supplement formulations, Nutralab has currently invested in-house for the enteric coated softgel facilities for health food supplement products.

What is the application of Enteric coating for? Some drugs, when given orally, should not be released immediately into the stomach but should be formulated so that they are only available for absorption in the upper or lower intestine or colon. The reasons for a delay until they are passed out of the stomach vary, but include: instability in an acid medium, for example, omeprazole; possible erosion and damage to the stomach wall by non- steroidal anti-inflammatory drugs, for example, diclofenac and gastric upset, for example, some erythromycin salts.

The normal means of preventing such problems is by coating a tablet containing the drug with an enteric layer.

An enteric layer is a coating of a substance which is insoluble in the acid medium of the stomach but which is soluble at the higher pH encountered in the intestine. Such materials are used as film coatings on tablets. Suitable film coating materials include methyl methacrylate polymers (as sold under the trademark Eudragit), cellulose acetate phthalate, polyvinyl acetate phthalate, and hydroxypropyl methyl phthalate. However, there is a problem with such tablets, particularly larger tablets because they may be retained in the stomach for a considerable time, for example, 4 to 8 hours, before releasing into the intestine. Such retention is unsuitable for drugs where prompt action is desired or where the absorption and blood levels should be maintained at a constant value.

It has been reported that some of these problems can be overcome with multiparticulate systems, wherein the dosage form breaks down in the stomach to form significantly smaller particles which pass through the stomach more quickly and reproducibly.